- Pfizer and BioNTech's results from their final stage clinical trial was published in a peer-reviewed journal this week
- They are the second of the leading Covid vaccine developers to have their data published
- The remaining two vaccine candidates are by Moderna and Johnson & Johnson's Janssen – the former is awaiting regulatory approval, while the latter's trials are still ongoing
Pfizer and BioNTech became the second Covid-19 vaccine frontrunner to have the full results of their human clinical trial published in the reputable New England Journal of Medicine on Thursday, after the US Food and Drug Administration (FDA) met to discuss its approval.
This came less than 48 hours after Oxford University and AstraZeneca’s vaccine results were published in The Lancet Medical Journal, as reported by Health24.
An editorial related to the scientific paper said: "The trial results are impressive enough to hold up in any conceivable analysis. This is a triumph."
The full trial included close to 44 000 volunteers. Around half of the volunteers received the vaccine and the rest a placebo (a substance with no therapeutic value).
The paper confirmed that a two-dose regimen of BNT162b2 was 95% effective in preventing Covid infection, and that the vaccine worked similarly across "age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions”.
Severe Covid in volunteers
Among 10 cases of severe Covid disease experienced after the first dose, nine occurred in placebo recipients and only one in a volunteer who received the vaccine.
However, the editorial that accompanied the study pointed out some "minor issues":
"The number of severe cases of Covid-19 (one in the vaccine group and nine in the placebo group) is too small to draw any conclusions about whether the rare cases that occur in vaccinated persons are actually more severe," it said.
Safety concerns also include whether more side effects will emerge with a longer follow-up of volunteers, as well as how long the vaccine remains effective. It is also not clear whether the jab will be safe and effective in children, pregnant women, and people with immunocompromised conditions.
Update on Moderna's vaccine
Drugmaker Moderna is also one of the leading Covid vaccine developers and announced its final results on 30 November, further stating that they are filing for US and European emergency-use authorisation for their mRNA vaccine, named mRNA-1273, so that it can be recommended for widespread use, Health24 previously reported.
The regulators are now in the process of assessing the biotechnology company’s trial data for the vaccine and will soon conclude whether it is safe and effective enough to recommend for rollout to the population.
According to CNBC, Moderna said on Thursday it had started its mid-to-late stage trial to test the vaccine in adolescents between the ages of 12 to 18 years.
J&J vaccine candidate still in trials
The third Covid vaccine frontrunner, JNJ-78436735, developed by Johnson & Johnson-owned Belgian company Janssen, is still being tested in its phase 3 trials.
On Thursday the company said they have cut the number of participants in the US trial of its vaccine from an initially planned 60 000 volunteers, to 40 000, due to a spike in cases in the US which means that volunteers are now more likely to be exposed to the virus, resulting in researchers testing the vaccine's efficacy, Business Insider SA reported.
The company already has close to 40 000 volunteers enrolled in the US trial. Trials testing the vaccine are also currently taking place in South Africa, Argentina, Brazil, Chile, Colombia, Mexico, and Peru.
Last month, J&J entered into an agreement with local pharmaceutical giant Aspen to package 300 million doses at its Port Elizabeth facility.
Aspen SA’s Group Executive Stephen Saad told Health24 that should the trials show positive results, manufacturing can begin as early as March 2021.
Moreover, J&J’s Chief Scientific Officer, Paul Stoffels confirmed to Spotlight that the firm expects to know in January 2021 whether the vaccine works to protect people against developing severe Covid illness.